title: Long-term exposure to belatacept in recipients of extended criteria donor kidneys.
abstract: Patients in the BENEFIT-EXT study received extended criteria donor kidneys and a more intensive (MI) or less intensive (LI) belatacept immunosuppression regimen, or cyclosporine A (CsA). Patients who remained on assigned therapy through year 3 were eligible to enter a long-term extension (LTE) study. Three hundred four patients entered the LTE (n = 104 MI; n = 113 LI; n = 87 CsA), and 260 continued treatment through year 5 (n = 91 MI; n = 100 LI; n = 69 CsA). Twenty patients died during the LTE (n = 5 MI; n = 9 LI; n = 6 CsA), and eight experienced graft loss (n = 2 MI; n = 1 LI; n = 5 CsA). Three patients experienced an acute rejection episode (n = 2 MI; n = 1 LI). The incidence rate of serious adverse events, viral infections and fungal infections was similar across groups during the LTE. There were four cases of posttransplant lymphoproliferative disorder (PTLD) from the beginning of the LTE to year 5 (n = 3 LI; n = 1 CsA); two of three PTLD cases in the LI group were in patients who were seronegative for Epstein-Barr virus (EBV(-)) at transplantation. Mean ± SD calculated GFR at year 5 was 55.9 ± 17.5 (MI), 59.0 ± 29.1 (LI) and 44.6 ± 16.4 (CsA) mL/min/1.73 m(2) . Continued treatment with belatacept was associated with a consistent safety profile and sustained improvement in renal function versus CsA over time.
authors.affiliation: Department of Nephrology, University Hospital of Bicêtre, Kremlin Bicêtre, IFNRT, UMR 1014 INSERM-Université Paris-Sud, Villejuif, France.
authors.forename: B
authors.initials: B
authors.lastname: Charpentier
authors.forename: J O
authors.initials: JO
authors.lastname: Medina Pestana
authors.forename: M
authors.initials: M
authors.lastname: Del C Rial
authors.forename: L
authors.initials: L
authors.lastname: Rostaing
authors.forename: J
authors.initials: J
authors.lastname: Grinyó
authors.forename: Y
authors.initials: Y
authors.lastname: Vanrenterghem
authors.forename: A
authors.initials: A
authors.lastname: Matas
authors.forename: R
authors.initials: R
authors.lastname: Zhang
authors.forename: F
authors.initials: F
authors.lastname: Mühlbacher
authors.forename: L
authors.initials: L
authors.lastname: Pupim
authors.forename: S
authors.initials: S
authors.lastname: Florman
mesh_terms: D000069594:Abatacept; D015331:Cohort Studies; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007390:International Agencies; D007676:Kidney Failure, Chronic / Q000601:surgery*; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008055:Lipids / Q000097:blood; D008232:Lymphoproliferative Disorders / Q000517:prevention & control; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D011379:Prognosis; D012449:Safety; D013997:Time Factors; D014019:Tissue Donors
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D008055:Lipids; D000069594:Abatacept; D016572:Cyclosporine
keywords: Belatacept; cyclosporine A; kidney; renal function